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Technical Writer/Materials expert

Business Type: Medical Devices Company
Job Type: Medical Devices
Job Level: Experienced (non manager)
Position: Full Time
Salary: EUR70000 - EUR80000 per annum + 8% pension, extra holidays
Location: Denmark
Reference: MS.242858.2
Closing Date: 22/06/20
Job Details:

Materials expert

  • Material evaluation (physical, mechanical and chemical properties)
  • Selection of materials and their characteristics to the intended purpose
  • Biological evaluation (EU + FDA)
  • Biocomp test selection
  • Test criteria estimation
  • Contact to test providers
  • Verification and approval of test documentation
  • Risk management (process and documentation)

Expected competences:

  1. Technical/medical writer (English)
  2. Scientific background - PhD degree
  3. Education: toxicology, material science
  4. Skills in collaborating with both subject-matter experts and co-workers.
  5. Ability to write clearly for specific audiences directed by clearly defined purposes.
  6. Ability to analyse user''s needs.
  7. Ability to gather data and analysis.
  8. Ability to assess and to learn to use technologies.
  9. Ability to critique one''s own work.
  10. Ability to take the initiative (be a self-starter) and to evaluate one''s own work and the work of others.
  11. Ability to achieve a set of expectations and values.
  12. Ability to conduct informational and problem-solving interviews.
  13. Ability to apply audience analysis to the design and writing of documents.
  14. Ability to write and field-test a technical manual.
  15. Ability to write technical documents as URS, test plans and reports, technical rationales, etc.
  16. Ability to prepare a complex documented technical/scientific report.
  17. Ability to reviews materials to ensure they are accurate, clear, concise.
  18. Ability to use skills of argument identification, analysis, and evaluation.
  19. Self-maintaining competences skills - Keep abreast of new relevant information, and undergo regular training and online courses to enhance skills. Self-identifying gaps and provide suggestions for solutions.
  20. Self-activation/evaluation skill: Ability for self-motivation and evaluation.
  21. Project management skills - Highly organised, proactive, respects metrics driven timelines and accountability for quality. Accepts responsibilities and delegates efficiently.
  22. Detail oriented.
  23. Material knowledge (metals, PTFE, HY coatings)
  24. Process knowledge (grinding, welding, coating)
  25. Good communication skills (with test providers and stakeholders)
  26. Preferable but not a requirement: Documented experience with ISO 10993, ISO 14971, ISO 13485, MDR and their equivalents in US, China, etc.
  27. Language requirements: English

Posted: 25/05/2020 | NPJ Ref: 254448
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